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Lorcaserin shows CV safety in CAMELLIA-TIMI 61
MUNICH – Lorcaserin is the first weight-loss drug proven to have cardiovascular safety, Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
MUNICH – Lorcaserin is the first weight-loss drug proven to have cardiovascular safety, Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
MUNICH – Lorcaserin is the first weight-loss drug proven to have cardiovascular safety, Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
Lorcaserin shows CV safety in CAMELLIA-TIMI 61
Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
The AGA Obesity Practice Guide provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.
Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
The AGA Obesity Practice Guide provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.
Erin A. Bohula, MD, DPhil, told Mitchel L. Zoler in an interview.
Dr. Bohula reported on the results of the CAMELLIA-TIMI 61 trial, which was designed to evaluate the cardiovascular safety of the weight-loss drug lorcaserin in more than 10,000 patients. She presented the data at the annual congress of the European Society of Cardiology.
In CAMELLIA-TIMI 61, the primary safety endpoint, a composite of cardiovascular death, MI, or stroke, was nearly identical between patients on lorcaserin and those given placebo, 2% and 2.1% per year, at P less than .001 for noninferiority. Similarly, the primary efficacy outcome comprising heart failure, hospitalization for unstable angina, and coronary revascularization, was very close between the treated and placebo patients, occurring in 4.1% and 4.2% per year, respectively.
In addition, “there was a sustained weight loss, more than with lifestyle alone or lifestyle plus placebo, which at its peak was about 3 kg. With that there were small, but significant, reductions in heart rate, blood pressure, triglycerides, and hemoglobin A1c, and there was a significant reduction in new-onset diabetes.”
“Overall, there’s not a lot of use of pharmacologic agents for weight loss in the United States, and a lot of that is based on fear of the historical experience, which is that they were not safe. I suspect that having a drug that is proven safe will now lead people to reach for a pharmacologic agent like lorcaserin,” said Dr. Bohula, a cardiologist at of Brigham and Women’s Hospital and an investigator at the TIMI study group.
The AGA Obesity Practice Guide provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.
REPORTING FROM THE ESC CONGRESS 2018
FOURIER analysis: PCSK9 inhibition helps MetS patients the most
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
mzoler@mdedge.com
On Twitter @mitchelzoler
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
Given the relatively high cost for the PCSK9 inhibitor drugs, clinicians need to know which patients are likely to get the biggest bang for the buck from these agents. This will be not just patients with the highest risks for cardiovascular disease events, but those with modifiable risk factors.
The finding of greater benefit from evolocumab in patients with metabolic syndrome seen in this new analysis of data from FOURIER is consistent with other reported analyses from this trial, which identified other markers of greater benefit such as peripheral artery disease, recent MIs, and multivessel coronary artery disease. The next step will be to try to put all these findings together and figure out which patients get the most benefit from treatment. If society can’t afford to treat all eligible patients with expensive PCSK9 inhibitors, we need to learn how to use these drugs in the most cost-effective way.
Stephen J. Nicholls, MD , is professor of cardiology at the University of Adelaide, Australia. He has received research funding from and has been a consultant to several drug companies including Amgen and Sanofi/Regeneron, the companies that market PCSK9 inhibitors. He made these comments in an interview.
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
mzoler@mdedge.com
On Twitter @mitchelzoler
MUNICH – Patients with hypercholesterolemia, atherosclerotic cardiovascular disease, and metabolic syndrome received a bigger benefit from treatment with a PCSK9 inhibitor than did otherwise similar patients without metabolic syndrome in a post hoc analysis of data collected from a placebo-controlled trial of a PCSK9 inhibitor with more than 27,000 total participants.
The analysis showed that patients with metabolic syndrome (MetS) treated with the proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor evolocumab in the FOURIER study had a statistically significant 17% relative risk reduction in the study’s primary efficacy endpoint compared with placebo, while those without MetS had an 11% relative risk reduction that did not reach statistical significance, Prakash Deedwania, MD, said at the annual congress of the European Society of Cardiology. “Given their higher baseline risk [for cardiovascular disease events], patients with metabolic syndrome had a larger absolute reduction in cardiovascular events,” said Dr. Deedwania, a professor of medicine at the University of California, San Francisco.
For the study’s secondary endpoint of the combined rate of cardiovascular disease death, nonfatal MI, and nonfatal stroke, patients with MetS treated with evolocumab had a statistically significant 24% relative risk reduction compared with placebo, while those without MetS had an insignificant 14% reduction. Dr. Deedwania and his associates calculated these relative risk reductions and those for the primary endpoint using adjustments for baseline differences between the MetS and non-MetS subgroups in age, race, sex, history of diabetes, history of MI, heart failure, smoking, renal function, LDL cholesterol levels, and use of a high-intensity dosage of a statin. Among the 27,342 patients enrolled in the trial 16,361 (60%) had MetS at entry into the study, which made this “the largest study ever reported for patients with metabolic syndrome,” he noted.
“Evolocumab was still effective in patients without metabolic syndrome, but it was of lesser magnitude, and that combined with the fewer patients in the non–metabolic syndrome subgroup meant the effect did not reach statistical significance,” Dr. Deedwania explained. “These data help identify the patients who benefit the most from treatment with an expensive drug,” a PCSK9 inhibitor. Based on list prices the annual cost for treatment with a PCSK9 inhibitor such as evolocumab (Repatha) or a second approved drug from this class, alirocumab (Praluent), is roughly $14,000 (JAMA Cardiol. 2017 Oct;2[10]:1066-8).
The analysis run by Dr. Deedwania used data collected in the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which had showed an overall relative risk reduction of 15% compared with placebo during a median follow-up of 2.2 years for the primary endpoint of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, or coronary revascularization (N Engl J Med. 2017 May 4;376[18]:1713-22). The study ran at 1,242 sites in 49 countries. He and his associates identified enrolled patients with MetS using the definition of the 2001 Third Report from the National Cholesterol Education Program: People with at least three of five criteria – fasting blood glucose of at least 100 mg/dL; waist circumference greater than 102 cm in men and 88 cm in women; systolic blood pressure of at least 135 mm Hg, diastolic blood pressure of at least 85 mm Hg, or a history of hypertension diagnosis; a triglyceride level greater than 150 mg/dL; and an HDL cholesterol level of less than 40 mg/dL in men and less than 50 mg/dL in women (JAMA. 2001 May 16;285[19]:2486-97).
The new analysis also showed that treatment with evolocumab led to an incremental, average reduction in LDL cholesterol of 58% in patients with MetS and 61% in patients without MetS at the time of enrollment. The patients with MetS in FOURIER overall had a significantly higher number of primary endpoint events, 15.8%, than enrolled patients without MetS, 12.9%, regardless of whether or not they received evolocumab, a relative risk of 21% more events after adjustment. The analysis also showed that treatment with evolocumab was equally safe and well tolerated by patients regardless of whether or not they had MetS, and that patients with MetS had no increased incidence of diabetes or elevations in fasting blood glucose or hemoglobin A1c while on treatment compared with those without MetS.
Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
mzoler@mdedge.com
On Twitter @mitchelzoler
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: PCSK9 inhibition produced the biggest benefit in patients with metabolic syndrome.
Major finding: In patients with metabolic syndrome, treatment with evolocumab cut the primary endpoint by a relative 17% compared with placebo.
Study details: Post hoc analysis of data from FOURIER, a multicenter, randomized trial with 27,342 patients.
Disclosures: Dr. Deedwania has been a consultant to Amgen, the company that markets evolocumab, and to Sanofi, the company that markets a different PCSK9 inhibitor, alirocumab.
VTE risk unchanged by rivaroxaban after discharge
For patients hospitalized for medical illness, giving rivaroxaban after discharge does not significantly reduce the risk of venous thromboembolism, investigators reported.
Previous research suggested that the risk of major bleeding from rivaroxaban outweighed its benefits; however, major bleeding was uncommon in the MARINER trial, reported lead author Alex C. Spyropoulos, MD, of Hofstra University in Hempstead, N.Y., and his colleagues.
“Patients who are hospitalized for acute medical illnesses, such as heart failure, respiratory insufficiency, stroke, and infectious or inflammatory diseases, are at increased risk for venous thromboembolism,” they wrote in the New England Journal of Medicine. The results were also presented at the annual congress of the European Society of Cardiology.
Although the increased risk of thromboembolism continues for at least 6 weeks after hospitalization, postdischarge anticoagulants, such as rivaroxaban, are controversial.
“Studies of extended thromboprophylaxis have shown either excess major bleeding or a benefit that is based mainly on reducing the risk of asymptomatic deep-vein thrombosis,” the investigators wrote.
The researchers aimed to clarify the benefits of rivaroxaban after hospitalization while modifying previous study regimens to limit major bleeding risk.
The double-blind MARINER study involved 12,019 patients who were hospitalized for medical illness and had an increased risk of venous thromboembolism. Hospitalization lasted 3-10 consecutive days. Sufficient risk of thromboembolism was defined by a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (range, 0-10), or an IMPROVE score of 2 or 3 with a plasma D-dimer measurement more than double the upper normal limit.
Patients were randomized to receive either 10 mg of rivaroxaban daily (n = 6,007) or placebo (n = 6,012) for 45 days after discharge. Patients with renal impairment had a reduced dose of 7.5 mg rivaroxaban.
A composite of symptomatic or fatal venous thromboembolism was the primary efficacy outcome. Major bleeding was the safety benchmark.
Efficacy was similar in both groups. Symptomatic or fatal venous thromboembolism occurred in 50 patients (0.83%) in the rivaroxaban group, compared with 66 patients (1.10%) in the placebo group (P = .14). These findings suggest that rivaroxaban provides a minor and insignificant benefit.
Although major bleeding was slightly more common in patients receiving rivaroxaban, compared with patients receiving placebo (0.28% vs. 0.15%), the researchers suggested that, in large populations, the marginal benefit of rivaroxaban might outweigh the increased bleeding risk. Still, the authors noted that “the usefulness of extended thromboprophylaxis remains uncertain.”
“Future studies should more accurately identify deaths caused by thrombotic mechanisms and focus on the patients who are at highest risk and who may benefit from anticoagulant prophylaxis,” the researchers wrote.
Funding was provided by Janssen Research and Development. Most of the study authors reported fees or grants from Janssen during the study, and relationships with other companies outside of the submitted work.
SOURCE : Spyropoulos AC et al. N Engl J Med. 2018 Aug 26. doi: 10.1056/NEJMoa1805090.
For patients hospitalized for medical illness, giving rivaroxaban after discharge does not significantly reduce the risk of venous thromboembolism, investigators reported.
Previous research suggested that the risk of major bleeding from rivaroxaban outweighed its benefits; however, major bleeding was uncommon in the MARINER trial, reported lead author Alex C. Spyropoulos, MD, of Hofstra University in Hempstead, N.Y., and his colleagues.
“Patients who are hospitalized for acute medical illnesses, such as heart failure, respiratory insufficiency, stroke, and infectious or inflammatory diseases, are at increased risk for venous thromboembolism,” they wrote in the New England Journal of Medicine. The results were also presented at the annual congress of the European Society of Cardiology.
Although the increased risk of thromboembolism continues for at least 6 weeks after hospitalization, postdischarge anticoagulants, such as rivaroxaban, are controversial.
“Studies of extended thromboprophylaxis have shown either excess major bleeding or a benefit that is based mainly on reducing the risk of asymptomatic deep-vein thrombosis,” the investigators wrote.
The researchers aimed to clarify the benefits of rivaroxaban after hospitalization while modifying previous study regimens to limit major bleeding risk.
The double-blind MARINER study involved 12,019 patients who were hospitalized for medical illness and had an increased risk of venous thromboembolism. Hospitalization lasted 3-10 consecutive days. Sufficient risk of thromboembolism was defined by a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (range, 0-10), or an IMPROVE score of 2 or 3 with a plasma D-dimer measurement more than double the upper normal limit.
Patients were randomized to receive either 10 mg of rivaroxaban daily (n = 6,007) or placebo (n = 6,012) for 45 days after discharge. Patients with renal impairment had a reduced dose of 7.5 mg rivaroxaban.
A composite of symptomatic or fatal venous thromboembolism was the primary efficacy outcome. Major bleeding was the safety benchmark.
Efficacy was similar in both groups. Symptomatic or fatal venous thromboembolism occurred in 50 patients (0.83%) in the rivaroxaban group, compared with 66 patients (1.10%) in the placebo group (P = .14). These findings suggest that rivaroxaban provides a minor and insignificant benefit.
Although major bleeding was slightly more common in patients receiving rivaroxaban, compared with patients receiving placebo (0.28% vs. 0.15%), the researchers suggested that, in large populations, the marginal benefit of rivaroxaban might outweigh the increased bleeding risk. Still, the authors noted that “the usefulness of extended thromboprophylaxis remains uncertain.”
“Future studies should more accurately identify deaths caused by thrombotic mechanisms and focus on the patients who are at highest risk and who may benefit from anticoagulant prophylaxis,” the researchers wrote.
Funding was provided by Janssen Research and Development. Most of the study authors reported fees or grants from Janssen during the study, and relationships with other companies outside of the submitted work.
SOURCE : Spyropoulos AC et al. N Engl J Med. 2018 Aug 26. doi: 10.1056/NEJMoa1805090.
For patients hospitalized for medical illness, giving rivaroxaban after discharge does not significantly reduce the risk of venous thromboembolism, investigators reported.
Previous research suggested that the risk of major bleeding from rivaroxaban outweighed its benefits; however, major bleeding was uncommon in the MARINER trial, reported lead author Alex C. Spyropoulos, MD, of Hofstra University in Hempstead, N.Y., and his colleagues.
“Patients who are hospitalized for acute medical illnesses, such as heart failure, respiratory insufficiency, stroke, and infectious or inflammatory diseases, are at increased risk for venous thromboembolism,” they wrote in the New England Journal of Medicine. The results were also presented at the annual congress of the European Society of Cardiology.
Although the increased risk of thromboembolism continues for at least 6 weeks after hospitalization, postdischarge anticoagulants, such as rivaroxaban, are controversial.
“Studies of extended thromboprophylaxis have shown either excess major bleeding or a benefit that is based mainly on reducing the risk of asymptomatic deep-vein thrombosis,” the investigators wrote.
The researchers aimed to clarify the benefits of rivaroxaban after hospitalization while modifying previous study regimens to limit major bleeding risk.
The double-blind MARINER study involved 12,019 patients who were hospitalized for medical illness and had an increased risk of venous thromboembolism. Hospitalization lasted 3-10 consecutive days. Sufficient risk of thromboembolism was defined by a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (range, 0-10), or an IMPROVE score of 2 or 3 with a plasma D-dimer measurement more than double the upper normal limit.
Patients were randomized to receive either 10 mg of rivaroxaban daily (n = 6,007) or placebo (n = 6,012) for 45 days after discharge. Patients with renal impairment had a reduced dose of 7.5 mg rivaroxaban.
A composite of symptomatic or fatal venous thromboembolism was the primary efficacy outcome. Major bleeding was the safety benchmark.
Efficacy was similar in both groups. Symptomatic or fatal venous thromboembolism occurred in 50 patients (0.83%) in the rivaroxaban group, compared with 66 patients (1.10%) in the placebo group (P = .14). These findings suggest that rivaroxaban provides a minor and insignificant benefit.
Although major bleeding was slightly more common in patients receiving rivaroxaban, compared with patients receiving placebo (0.28% vs. 0.15%), the researchers suggested that, in large populations, the marginal benefit of rivaroxaban might outweigh the increased bleeding risk. Still, the authors noted that “the usefulness of extended thromboprophylaxis remains uncertain.”
“Future studies should more accurately identify deaths caused by thrombotic mechanisms and focus on the patients who are at highest risk and who may benefit from anticoagulant prophylaxis,” the researchers wrote.
Funding was provided by Janssen Research and Development. Most of the study authors reported fees or grants from Janssen during the study, and relationships with other companies outside of the submitted work.
SOURCE : Spyropoulos AC et al. N Engl J Med. 2018 Aug 26. doi: 10.1056/NEJMoa1805090.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point:
Major finding: Symptomatic or fatal venous thromboembolism occurred in 0.83% of patients given rivaroxaban, compared with 1.10% of patients given placebo (P = .14).
Study details: The MARINER study was a double-blind, randomized trial involving 12,019 patients. Patients were recently hospitalized for medical illness and had an increased risk of venous thromboembolism.
Disclosures: Funding was provided by Janssen Research and Development. Most of the study authors reported fees or grants from Janssen during the study, and relationships with other companies outside of the submitted work.
Source: Spyropoulos AC et al. N Engl J Med. 2018 Aug 26. doi: 10.1056/NEJMoa1805090.
Restrictive transfusions do not increase long-term CV surgery risk
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: A restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months.
Major finding: At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive approach).
Study details: Randomized, multicenter trial with over 5,000 surgery patients
Disclosures: The work was funded by the Canadian Institutes of Health Research, among others. The lead investigator had no relevant disclosures.
Source: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
Culprit-vessel PCI may be safer long term in cardiogenic shock
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
At 30 days, culprit lesion–only PCI was associated with fewer cases of death or renal replacement therapy than immediate multivessel PCI.
However, not all the news was good for culprit lesion–only PCI: At 1 year, it was associated with a higher frequency of rehospitalization for heart failure and of repeat vascularization, according to Holger Thiele, MD, of the Heart Center Leipzig at the University of Leipzig (Germany) and his colleagues.
These results from the Culprit Only Lesion PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) study were presented at the annual congress of the European Society of Cardiology and published simultaneously in the New England Journal of Medicine.
The 30-day results from the study, published in the journal last year, were enough to convince the creators of the European revascularization guidelines to downgrade immediate multivessel PCI in cardiogenic shock to a class III B recommendation, which indicates that it is not effective and may cause harm.
However, the results also caused controversy because complete revascularization via immediate multivessel PCI in cardiogenic shock patients might lead to long-term benefits. In fact, evidence from nonrandomized trials and a registry study had suggested that immediate multivessel PCI may reduce mortality at 1 year.
But the new 1-year data don’t support that hypothesis of long-term benefit, Dr. Thiele and his colleagues found.
The CULPRIT-SHOCK trial randomized 684 patients at 83 centers to culprit lesion–only PCI or multivessel PCI. At 30 days, death or renal replacement therapy occurred at a lower frequency in the culprit lesion–only group (45.9% vs. 55.4%; relative risk, 0.83; P = .01).
At 1 year, all-cause mortality was 50.0% in the group that underwent culprit lesion–only PCI, compared with 56.9% in the group that underwent multivessel PCI, a result that was not statistically significant (RR, 0.88; 95% CI, 0.76-1.01). There was also no significant difference in death from cardiovascular causes, 46.2% in culprit lesion–only patients, compared with 52.8% in multivessel patients (RR, 0.88; 95% CI, 0.75-1.02).
Mortality rates between baseline and 1 year were similar in the intention-to-treat, per-protocol, and as-treated populations.
The researchers conducted a post hoc analysis of the original primary endpoint – death or renal replacement therapy – at 1 year, and they found results similar to those seen at 30 days: 52.0% in the culprit lesion–only group and 59.5% in the multivessel group (RR, 0.87; 95% CI, 0.76-0.99).
Some results favored multivessel PCI: 32.3% of the culprit lesion–only group underwent repeat revascularization, compared with 9.4% of multivessel PCI (RR, 3.44; 95% CI, 2.39-4.95). Rehospitalizations for congestive heart failure were rare, but occurred in 5.2% of the culprit lesion–only group, compared with 1.2% of the multivessel group (RR, 4.46; 95% CI, 1.53-13.04).
The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
SOURCE: Thiele H et al. N Engl J Med. 2018 Aug 2
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: Culprit-vessel PCI may be safer than multivessel PCI.
Major finding: At 1 year, treating patients with acute MI, cardiogenic shock, and multivessel coronary artery disease with either culprit-vessel PCI or multivessel PCI had similar mortality rates.
Study details: A randomized, controlled trial of 684 patients.
Disclosures: The study was funded by the European Union Seventh Framework Programme, the German Heart Research Foundation, and the German Centre for Cardiovascular Research. Dr. Thiele had no relevant conflicts of interest.
Source: Thiele H et al. N Engl J Med. 2018 Aug 25. doi: 10.1056/NEJMoa1808788.
SCOT-HEART: CTA cuts MIs in patients with stable chest pain
MUNICH –
Although the absolute numbers were small – 48 clinical events in the intervention group and 81 among patients who had standard care – the difference was significant and wasn’t associated with any increase in invasive coronary procedures, David E. Newby, MD, said at the annual congress of the European Society of Cardiology.
The study, presented August 25, was published simultaneously in the New England Journal of Medicine (NEJM 2018; DOI: 10.1056/NEJMoa1805971
The data suggest that 63 patients with stable chest pain would need to undergo CTA to prevent one fatal or nonfatal myocardial infarction over 5 years, said Dr. Newby, the BHF John Wheatley professor of cardiology at the University of Edinburgh, Scotland.
He presented 5-year results of the SCOT-HEART study, an open-label trial that randomized 4,146 patients with stable chest pain to standard care plus CTA, or standard care alone. The primary endpoint was nonfatal myocardial infarction or death from coronary heart disease at 5 years. The 3-year results were previously reported.
“This is one of the most impactful studies in cardiovascular medicine. It’s a groundbreaking trial,” commented Todd C. Villines, MD, a designated discussant for the report at the meeting. SCOT-HEART “looked at the additive value of CTA compared with usual care using functional testing with an exercise stress test. It showed that when you visualize coronary atherosclerosis [with CTA] and change medical management based on whether or not plaque is present it drove a significant decrease in MIs,” noted Dr. Villines, a cardiologist affiliated with Georgetown University Medical School in Washington, and immediate past president of the Society of Cardiovascular CT.
Patients were recruited from 12 cardiology centers across Scotland and followed for a mean of 4.8 years, amassing 20,254 patient-years of follow-up. They were a mean of 57 years old; 41% had nonanginal chest pain, 35% typical angina, and 24% atypical angina About half were current or former smokers, a third had hypertension, and half had hypercholesterolemia. Resting EEG was normal in 85%.
Patients who underwent CTA were more likely to start preventive therapies (19% vs. 14.7%; odds ratio, 1.4) and antianginal therapies (13% vs. 10.7%; hazard ratio, 1.27). And although there were more revascularizations in that group early on, the numbers were similar by the end of follow-up (13.5% vs. 13%). After 12 months, CTA patients were 30% less likely to undergo invasive coronary angiography (HR, 0.70) and 41% less likely to undergo a coronary revascularization (HR, 0.59).
“This would be consistent with both the emergence of unrecognized disease and nonfatal myocardial infarction in the standard-care group and the reduction in disease progression in the CTA group owing to the implementation of lifestyle modifications and preventive therapies,” Dr. Newby and colleagues wrote in the NEJM paper.
The composite clinical endpoint occurred in 2.3% of the CTA group and 3.9% of the standard care group – a significant risk differential of 41% (HR, 0.59). The primary driver of this benefit was a significantly lower rate of nonfatal myocardial infarction (HR, 0.60) among CTA patients.
There was no evidence of a subgroup effect, Dr. Newby noted. Among the 48 CTA patients who experienced a clinical event, 22 had obstructive disease, 17 had nonobstructive disease, and three had normal coronary arteries (six patients assigned to the procedure didn’t return for it).
There was a slightly higher event rate among patients with possible angina than among those with nonanginal pain (3.1% vs. 1.8%), but the 5-year difference between the treatment groups was not significantly different.
“Our findings suggest that the use of CTA resulted in more correct diagnoses of coronary heart disease than standard care alone, which, in turn, led to the use of appropriate therapies and this change in management resulted in fewer clinical events in the CTA group than in the standard-care group,” Dr. Newby noted. “Patients who receive a correct diagnosis are also more likely to receive appropriate preventive therapies and may have greater motivation to implement healthy lifestyle modification.”
“The SCOT-HEART data solidify coronary CTA as the best first-line test for patients without established coronary disease,” especially now that a report documented that clinicians worldwide are performing coronary CTA using lower levels of radiation exposure to patients, commented Dr. Villines in an interview. During the same session where Dr. Newby reported the SCOT-HEART results, an international team of researchers reported results of a survey of CTA methods used at 61 centers in 32 countries, including several U.S. sites. The results from the survey showed that in 2017 patients undergoing coronary CTA received a median radiation dose of 2.7 mSv and a median dose-length product of 195 mGy*cm, both representing a 78% relative reduction compared with the median doses received during CTA when a similar survey ran in 2007 (Eur Heart J. 2018 Aug 25; doi:10.1093/eurheartj/ehy546).
In contrast, for patients with established coronary artery disease functional tests using stress imaging remain best, Dr. Villines said. “What SCOT-HEART said was that when you use coronary CTA in a population without established coronary disease you can identify not only whether the patient has obstructive disease but do they have coronary atherosclerosis, and that is prognostic and valuable. You miss that with functional testing.”
The Chief Scientist Office of the Scottish Government funded the study. Dr. Newby has received grants from Seimens. Dr. Villines had no relevant commercial disclosures.
Updated 8/27/18: Mitchel L. Zoler contributed commentary by Dr. Todd C. Villines, and additional data and discussion from the presentation, to this article.
SOURCE: Newby DE et al. NEJM 2018; DOI: 10.1056/NEJMoa1805971.
Clinical information gleaned from CTA can drive the treatment of chest pain far beyond simply making a correct diagnosis, Udo Hoffmann, MD, and James Udelson, MD, wrote in an accompanying editorial (NEJM 2018 DOI: 10.1056/NEJMo1809203).
The 41% lower rate of nonfatal myocardial infarction or death from coronary heart disease seen in the 5-year SCOT-HEART data came without the additional financial or clinical cost of invasive coronary procedures.
“The relative risk reductions observed in the SCOT-HEART trial are like those observed in recent secondary prevention trials, which prompts speculation about the mechanism. In trials of diagnostic testing strategies, it is the downstream management – presumably driven by the testing results – that affects outcomes.”
Coronary revascularization probably didn’t play a major role in the benefit, given the similar between-group rates. So, the key must lie elsewhere. A look at a similar study, which found quite different results, may help.
The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) randomized similar chest pain patients to either CTA or functional testing but showed no significant benefit of CTA over 2 years. It compared CTA primarily to nuclear imaging or echocardiogram, with only 10% getting an exercise ECG. In SCOT-HEART the comparator standardized strategy was predominantly stress ECG testing, and only 10% had an imaging test.
“An analysis of PROMISE shows that a substantial proportion of myocardial infarctions occurred in patients with nonobstructive coronary artery disease identified by CTA – disease that would not be detected by functional testing. It would be reasonable to consider aggressive secondary prevention in these patients, although this specific approach has not been evaluated in a clinical trial. We also believe that leveraging data from trials such as SCOT-HEART and PROMISE may allow more efficient targeting of noninvasive testing while continuing to drive improvement in vascular outcomes.”
Dr. Hoffmann is a cardiac radiologist at Harvard Medical School and Dr. Udelson is director of the Nuclear Cardiology Laboratory at Tufts Medical Center, both of Boston.
Clinical information gleaned from CTA can drive the treatment of chest pain far beyond simply making a correct diagnosis, Udo Hoffmann, MD, and James Udelson, MD, wrote in an accompanying editorial (NEJM 2018 DOI: 10.1056/NEJMo1809203).
The 41% lower rate of nonfatal myocardial infarction or death from coronary heart disease seen in the 5-year SCOT-HEART data came without the additional financial or clinical cost of invasive coronary procedures.
“The relative risk reductions observed in the SCOT-HEART trial are like those observed in recent secondary prevention trials, which prompts speculation about the mechanism. In trials of diagnostic testing strategies, it is the downstream management – presumably driven by the testing results – that affects outcomes.”
Coronary revascularization probably didn’t play a major role in the benefit, given the similar between-group rates. So, the key must lie elsewhere. A look at a similar study, which found quite different results, may help.
The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) randomized similar chest pain patients to either CTA or functional testing but showed no significant benefit of CTA over 2 years. It compared CTA primarily to nuclear imaging or echocardiogram, with only 10% getting an exercise ECG. In SCOT-HEART the comparator standardized strategy was predominantly stress ECG testing, and only 10% had an imaging test.
“An analysis of PROMISE shows that a substantial proportion of myocardial infarctions occurred in patients with nonobstructive coronary artery disease identified by CTA – disease that would not be detected by functional testing. It would be reasonable to consider aggressive secondary prevention in these patients, although this specific approach has not been evaluated in a clinical trial. We also believe that leveraging data from trials such as SCOT-HEART and PROMISE may allow more efficient targeting of noninvasive testing while continuing to drive improvement in vascular outcomes.”
Dr. Hoffmann is a cardiac radiologist at Harvard Medical School and Dr. Udelson is director of the Nuclear Cardiology Laboratory at Tufts Medical Center, both of Boston.
Clinical information gleaned from CTA can drive the treatment of chest pain far beyond simply making a correct diagnosis, Udo Hoffmann, MD, and James Udelson, MD, wrote in an accompanying editorial (NEJM 2018 DOI: 10.1056/NEJMo1809203).
The 41% lower rate of nonfatal myocardial infarction or death from coronary heart disease seen in the 5-year SCOT-HEART data came without the additional financial or clinical cost of invasive coronary procedures.
“The relative risk reductions observed in the SCOT-HEART trial are like those observed in recent secondary prevention trials, which prompts speculation about the mechanism. In trials of diagnostic testing strategies, it is the downstream management – presumably driven by the testing results – that affects outcomes.”
Coronary revascularization probably didn’t play a major role in the benefit, given the similar between-group rates. So, the key must lie elsewhere. A look at a similar study, which found quite different results, may help.
The Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) randomized similar chest pain patients to either CTA or functional testing but showed no significant benefit of CTA over 2 years. It compared CTA primarily to nuclear imaging or echocardiogram, with only 10% getting an exercise ECG. In SCOT-HEART the comparator standardized strategy was predominantly stress ECG testing, and only 10% had an imaging test.
“An analysis of PROMISE shows that a substantial proportion of myocardial infarctions occurred in patients with nonobstructive coronary artery disease identified by CTA – disease that would not be detected by functional testing. It would be reasonable to consider aggressive secondary prevention in these patients, although this specific approach has not been evaluated in a clinical trial. We also believe that leveraging data from trials such as SCOT-HEART and PROMISE may allow more efficient targeting of noninvasive testing while continuing to drive improvement in vascular outcomes.”
Dr. Hoffmann is a cardiac radiologist at Harvard Medical School and Dr. Udelson is director of the Nuclear Cardiology Laboratory at Tufts Medical Center, both of Boston.
MUNICH –
Although the absolute numbers were small – 48 clinical events in the intervention group and 81 among patients who had standard care – the difference was significant and wasn’t associated with any increase in invasive coronary procedures, David E. Newby, MD, said at the annual congress of the European Society of Cardiology.
The study, presented August 25, was published simultaneously in the New England Journal of Medicine (NEJM 2018; DOI: 10.1056/NEJMoa1805971
The data suggest that 63 patients with stable chest pain would need to undergo CTA to prevent one fatal or nonfatal myocardial infarction over 5 years, said Dr. Newby, the BHF John Wheatley professor of cardiology at the University of Edinburgh, Scotland.
He presented 5-year results of the SCOT-HEART study, an open-label trial that randomized 4,146 patients with stable chest pain to standard care plus CTA, or standard care alone. The primary endpoint was nonfatal myocardial infarction or death from coronary heart disease at 5 years. The 3-year results were previously reported.
“This is one of the most impactful studies in cardiovascular medicine. It’s a groundbreaking trial,” commented Todd C. Villines, MD, a designated discussant for the report at the meeting. SCOT-HEART “looked at the additive value of CTA compared with usual care using functional testing with an exercise stress test. It showed that when you visualize coronary atherosclerosis [with CTA] and change medical management based on whether or not plaque is present it drove a significant decrease in MIs,” noted Dr. Villines, a cardiologist affiliated with Georgetown University Medical School in Washington, and immediate past president of the Society of Cardiovascular CT.
Patients were recruited from 12 cardiology centers across Scotland and followed for a mean of 4.8 years, amassing 20,254 patient-years of follow-up. They were a mean of 57 years old; 41% had nonanginal chest pain, 35% typical angina, and 24% atypical angina About half were current or former smokers, a third had hypertension, and half had hypercholesterolemia. Resting EEG was normal in 85%.
Patients who underwent CTA were more likely to start preventive therapies (19% vs. 14.7%; odds ratio, 1.4) and antianginal therapies (13% vs. 10.7%; hazard ratio, 1.27). And although there were more revascularizations in that group early on, the numbers were similar by the end of follow-up (13.5% vs. 13%). After 12 months, CTA patients were 30% less likely to undergo invasive coronary angiography (HR, 0.70) and 41% less likely to undergo a coronary revascularization (HR, 0.59).
“This would be consistent with both the emergence of unrecognized disease and nonfatal myocardial infarction in the standard-care group and the reduction in disease progression in the CTA group owing to the implementation of lifestyle modifications and preventive therapies,” Dr. Newby and colleagues wrote in the NEJM paper.
The composite clinical endpoint occurred in 2.3% of the CTA group and 3.9% of the standard care group – a significant risk differential of 41% (HR, 0.59). The primary driver of this benefit was a significantly lower rate of nonfatal myocardial infarction (HR, 0.60) among CTA patients.
There was no evidence of a subgroup effect, Dr. Newby noted. Among the 48 CTA patients who experienced a clinical event, 22 had obstructive disease, 17 had nonobstructive disease, and three had normal coronary arteries (six patients assigned to the procedure didn’t return for it).
There was a slightly higher event rate among patients with possible angina than among those with nonanginal pain (3.1% vs. 1.8%), but the 5-year difference between the treatment groups was not significantly different.
“Our findings suggest that the use of CTA resulted in more correct diagnoses of coronary heart disease than standard care alone, which, in turn, led to the use of appropriate therapies and this change in management resulted in fewer clinical events in the CTA group than in the standard-care group,” Dr. Newby noted. “Patients who receive a correct diagnosis are also more likely to receive appropriate preventive therapies and may have greater motivation to implement healthy lifestyle modification.”
“The SCOT-HEART data solidify coronary CTA as the best first-line test for patients without established coronary disease,” especially now that a report documented that clinicians worldwide are performing coronary CTA using lower levels of radiation exposure to patients, commented Dr. Villines in an interview. During the same session where Dr. Newby reported the SCOT-HEART results, an international team of researchers reported results of a survey of CTA methods used at 61 centers in 32 countries, including several U.S. sites. The results from the survey showed that in 2017 patients undergoing coronary CTA received a median radiation dose of 2.7 mSv and a median dose-length product of 195 mGy*cm, both representing a 78% relative reduction compared with the median doses received during CTA when a similar survey ran in 2007 (Eur Heart J. 2018 Aug 25; doi:10.1093/eurheartj/ehy546).
In contrast, for patients with established coronary artery disease functional tests using stress imaging remain best, Dr. Villines said. “What SCOT-HEART said was that when you use coronary CTA in a population without established coronary disease you can identify not only whether the patient has obstructive disease but do they have coronary atherosclerosis, and that is prognostic and valuable. You miss that with functional testing.”
The Chief Scientist Office of the Scottish Government funded the study. Dr. Newby has received grants from Seimens. Dr. Villines had no relevant commercial disclosures.
Updated 8/27/18: Mitchel L. Zoler contributed commentary by Dr. Todd C. Villines, and additional data and discussion from the presentation, to this article.
SOURCE: Newby DE et al. NEJM 2018; DOI: 10.1056/NEJMoa1805971.
MUNICH –
Although the absolute numbers were small – 48 clinical events in the intervention group and 81 among patients who had standard care – the difference was significant and wasn’t associated with any increase in invasive coronary procedures, David E. Newby, MD, said at the annual congress of the European Society of Cardiology.
The study, presented August 25, was published simultaneously in the New England Journal of Medicine (NEJM 2018; DOI: 10.1056/NEJMoa1805971
The data suggest that 63 patients with stable chest pain would need to undergo CTA to prevent one fatal or nonfatal myocardial infarction over 5 years, said Dr. Newby, the BHF John Wheatley professor of cardiology at the University of Edinburgh, Scotland.
He presented 5-year results of the SCOT-HEART study, an open-label trial that randomized 4,146 patients with stable chest pain to standard care plus CTA, or standard care alone. The primary endpoint was nonfatal myocardial infarction or death from coronary heart disease at 5 years. The 3-year results were previously reported.
“This is one of the most impactful studies in cardiovascular medicine. It’s a groundbreaking trial,” commented Todd C. Villines, MD, a designated discussant for the report at the meeting. SCOT-HEART “looked at the additive value of CTA compared with usual care using functional testing with an exercise stress test. It showed that when you visualize coronary atherosclerosis [with CTA] and change medical management based on whether or not plaque is present it drove a significant decrease in MIs,” noted Dr. Villines, a cardiologist affiliated with Georgetown University Medical School in Washington, and immediate past president of the Society of Cardiovascular CT.
Patients were recruited from 12 cardiology centers across Scotland and followed for a mean of 4.8 years, amassing 20,254 patient-years of follow-up. They were a mean of 57 years old; 41% had nonanginal chest pain, 35% typical angina, and 24% atypical angina About half were current or former smokers, a third had hypertension, and half had hypercholesterolemia. Resting EEG was normal in 85%.
Patients who underwent CTA were more likely to start preventive therapies (19% vs. 14.7%; odds ratio, 1.4) and antianginal therapies (13% vs. 10.7%; hazard ratio, 1.27). And although there were more revascularizations in that group early on, the numbers were similar by the end of follow-up (13.5% vs. 13%). After 12 months, CTA patients were 30% less likely to undergo invasive coronary angiography (HR, 0.70) and 41% less likely to undergo a coronary revascularization (HR, 0.59).
“This would be consistent with both the emergence of unrecognized disease and nonfatal myocardial infarction in the standard-care group and the reduction in disease progression in the CTA group owing to the implementation of lifestyle modifications and preventive therapies,” Dr. Newby and colleagues wrote in the NEJM paper.
The composite clinical endpoint occurred in 2.3% of the CTA group and 3.9% of the standard care group – a significant risk differential of 41% (HR, 0.59). The primary driver of this benefit was a significantly lower rate of nonfatal myocardial infarction (HR, 0.60) among CTA patients.
There was no evidence of a subgroup effect, Dr. Newby noted. Among the 48 CTA patients who experienced a clinical event, 22 had obstructive disease, 17 had nonobstructive disease, and three had normal coronary arteries (six patients assigned to the procedure didn’t return for it).
There was a slightly higher event rate among patients with possible angina than among those with nonanginal pain (3.1% vs. 1.8%), but the 5-year difference between the treatment groups was not significantly different.
“Our findings suggest that the use of CTA resulted in more correct diagnoses of coronary heart disease than standard care alone, which, in turn, led to the use of appropriate therapies and this change in management resulted in fewer clinical events in the CTA group than in the standard-care group,” Dr. Newby noted. “Patients who receive a correct diagnosis are also more likely to receive appropriate preventive therapies and may have greater motivation to implement healthy lifestyle modification.”
“The SCOT-HEART data solidify coronary CTA as the best first-line test for patients without established coronary disease,” especially now that a report documented that clinicians worldwide are performing coronary CTA using lower levels of radiation exposure to patients, commented Dr. Villines in an interview. During the same session where Dr. Newby reported the SCOT-HEART results, an international team of researchers reported results of a survey of CTA methods used at 61 centers in 32 countries, including several U.S. sites. The results from the survey showed that in 2017 patients undergoing coronary CTA received a median radiation dose of 2.7 mSv and a median dose-length product of 195 mGy*cm, both representing a 78% relative reduction compared with the median doses received during CTA when a similar survey ran in 2007 (Eur Heart J. 2018 Aug 25; doi:10.1093/eurheartj/ehy546).
In contrast, for patients with established coronary artery disease functional tests using stress imaging remain best, Dr. Villines said. “What SCOT-HEART said was that when you use coronary CTA in a population without established coronary disease you can identify not only whether the patient has obstructive disease but do they have coronary atherosclerosis, and that is prognostic and valuable. You miss that with functional testing.”
The Chief Scientist Office of the Scottish Government funded the study. Dr. Newby has received grants from Seimens. Dr. Villines had no relevant commercial disclosures.
Updated 8/27/18: Mitchel L. Zoler contributed commentary by Dr. Todd C. Villines, and additional data and discussion from the presentation, to this article.
SOURCE: Newby DE et al. NEJM 2018; DOI: 10.1056/NEJMoa1805971.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: Coronary computed tomographic angiography reduced the risk of poor cardiovascular outcomes in patients with stable chest pain.
Major finding: Patients who had CTA were 41% less likely to have a nonfatal heart attack or cardiovascular death at 5 years.
Study details: SCOT-HEART randomized 4,146 patients to either CTA or standard diagnostic care.
Disclosures: The Chief Scientist Office of the Scottish Government funded the study. Dr. Newby has received grants from Seimens.
Source: Newby DE et al. NEJM 2018; DOI: 10.1056/NEJMoa1805971.